Novavax announces FDA approval of BLA for COVID-19 vaccine

Novavax (NVAX) announced that the U.S. FDA has approved the Biologics License Application for Nuvaxovid for active immunization to prevent coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2 in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. Achievement of the U.S. license approval has triggered a $175M milestone payment from Sanofi (SNY). The approval triggers a $175M milestone payment under the collaboration and license agreement between Novavax and Sanofi signed in May 2024. The agreement has layers of value for Novavax. Sanofi is leading on commercialization efforts starting this year and Novavax is eligible to receive ongoing tiered royalties from stand-alone COVID-19 vaccine sales for all future vaccination seasons.